Generic Branding

Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management

FDA advisory committee recommends approval of Exubera inhaled insulin A Food and Drug Administration advisory committee recommended approval of Pfizer Inc. and sanofi-aventis Group's inhaled insulin powder, Exubera (rDNA origin).

The panel voted 7-2 in favor of approving Exubera, which is inhaled using a device developed by Nektar Therapeutics, according to Dow Jones Newswires. The drug is intended to treat adults with type 1 or type 2 diabetes.

Dow Jones said the FDA is concerned about pulmonary safety among patients taking Exubera, as studies have shown that some individuals experience a slight decline in lung function. According to briefing documents on the FDA's Web site, the declines are "small, nonprogressive beyond two weeks and reversible following cessation of treatment."

An FDA medical officer said during the committee meeting that while there was a "numeric decline" in lung function observed among patients treated with Exubera compared with patients who did not receive the drug, the difference was not "clinically significant."

The FDA was favorably impressed with the seven studies Pfizer chose to submit (out of more than 50 studies conducted) in support of Exubera, Dow Jones reported. The seven studies involved more than 2,000 patients, some of whom had been treated with the drug for more than seven years.

FDA briefing documents said that because Exubera delivers insulin by "an alternative, noninvasive route of administration, (it) represents the next major therapeutic advance" in the history of diabetes treatment.

Generic Branding

Biogen Idec to reduce workforce by 17 percent, divest certain assets In an effort to promote long-term growth, Biogen Idec Inc. devised a strategic plan that includes cutting 17 percent of its workforce and reallocating resources connected to programs that are not likely to "create significant value."

The company will eliminate approximately 650 positions across all departments, sites and company functions. This action is expected to be "substantially implemented" by the end of the year, and Biogen Idec expects to incur a pre-tax charge of $30 million to $40 million in related costs. Biogen Idec also intends to divest several noncore assets, such as its treatment for chronic plaque psoriasis, Amevive (alefacept), and a manufacturing facility in San Diego.

Overall, Biogen Idec expects to save approximately $200 million to $300 million in annual operating costs as a result of these steps.

As part of its new plan, the company said it will focus on core business strengths associated with multiple sclerosis drug Avonex (interferon beta-1a) and non-Hodgkin's lymphoma treatment Rituxan (rituximab), which it copromotes in the United States with Genentech Inc. Biogen Idec also plans to focus on regulatory discussions regarding the company and Elan Corp. Plc's withdrawn MS drug, Tysabri (natalizumab), and the U.S. launch of Rituxan for rheumatoid arthritis.

Generic Branding

FDA raises concerns of heart failure, cancer for BMS, Merck's diabetes drug candidate, Pargluva Food and Drug Administration regulatory staff members concluded that Pargluva (muraglitazar), a diabetes drug codeveloped by Bristol-Myers Squibb Co. and Merck & Co. Inc., is effective, but they cautioned that it is unclear whether the drug may lead to heart damage.

According to regulatory documents, heart failure cases with Pargluva were "of mild to moderate severity, and most events resolved within days" after diuretics were administered and the drug was discontinued.

Based on data related to myocardial infarctions and other cardiovascular problems, the FDA staff concluded that "[b]ecause of the inconsistencies between studies, these results are difficult to interpret, and the clinical significance is unclear."

An FDA advisory panel is scheduled to meet today to discuss recommendation of Pargluva for the U.S. market. According to Reuters, if the drug is approved, it would be the first of a new class of drugs called glitizars to gain regulatory approval. Glitizars are designed to treat diabetes by combining increased insulin sensitization with control of blood lipids; they also target cholesterol and other blood fats.

The FDA said that although 2.5 mg and 5 mg doses of Pargluva successfully controlled sugar levels, the drug's side effects included fluid retention that could result in congestive heart failure. Officials at the agency said Pargluva's cardiovascular risk will be "a central issue" at the meeting.

The regulatory staff also voiced concern about the high incidence of bladder and kidney cancers Pargluva demonstrated in earlier studies of rodents, adding that "the clinical significance of the preclinical findings has not been established at this time."

Generic Branding

Diovan as effective as captopril in reducing MI, new VALIANT analysis shows Novartis AG presented data from a new analysis of VALIANT trial results, confirming that its angiotensin receptor blocker, Diovan (valsartan), is as effective as the ACE inhibitor captopril in reducing atherosclerotic events such as myocardial infarction.

The VALIANT trial included 14,703 patients who were at a high risk of death after an MI. Patients were randomized to treatment with Diovan, captopril or a combination of the two.

No significant difference was observed between the effects of Diovan or captopril on the composite endpoint of MI, cardiovascular death, angina, revascularization or stroke, Novartis said, adding that this makes Diovan "the only cardiovascular agent ever shown by a head-to-head trial to be at least as effective as an ACE inhibitor in these patients."

According to Novartis, this finding translates into Diovan reducing the chance of premature death by 25 percent in high-risk patients following an MI. While there were no differences in overall mortality between the treatment groups, the patients treated with Diovan showed improved survival and reduced cardiovascular events, including recurrent MI and hospitalizations for heart failure.

These data were presented at the European Society of Cardiology Congress 2005 in Stockholm, Sweden.

"Until now, the nature of ARB trials [has] made it difficult to determine whether this class of drugs is effective in preventing atherosclerotic events," said Dr. John McMurray, a principal investigator in the trial, which was the basis of the hypertension drug's recently expanded indication of reducing cardiovascular mortality in patients who are at high risk--due to left ventricular failure or dysfunction--after MI.

The Food and Drug Administration also recently expanded Diovan's product labeling. Prescribing of the drug is no longer restricted to patients who are unable to tolerate ACE inhibitors; it can now be prescribed to a broader group of patients who have experienced heart failure.

Generic Branding

Researchers report statin therapy administered within 24 hours of AMI reduces in-hospital mortality, early complications Administration of statin therapy within 24 hours of hospital admission for acute myocardial infarction (AMI) is associated with significant reductions in early complications and in-hospital mortality, suggest findings from a new analysis.

Researchers evaluated data from the National Registry of Myocardial Infarction 4 (NRMI 4), a prospective observational database of patients admitted with AMI to 1,230 participating U.S. hospitals. From July 2000 to January 2002, data were collected on a total of 300,823 patients with AMI.

The current analysis focused on 21,978 patients who began statin therapy within the first 24 hours of hospitalization; 17,118 patients who continued statin therapy that began prior to admission; 126,128 patients who did not receive statin therapy before or within the first 24 hours of hospitalization; and 9,411 patients for whom statin therapy was discontinued.

Compared with no statin treatment, initiation of statin therapy within the first 24 hours of admission was associated with a substantial reduction in risk of in-hospital mortality (15.4 percent vs. 4.0 percent), as was continuation of statin therapy (5.3 percent). Meanwhile, risk of in-hospital mortality was slightly higher among patients who discontinued statin therapy as compared with those who did not use statins (16.5 percent vs. 15.4 percent).

After adjustment for statin propensity and potential confounding variables, patients who newly initiated statin therapy within 24 hours of admission persisted in having a significantly reduced risk of in-hospital mortality compared with those who did not use statins; the risk was also lower for patients who received statin therapy prior to and continued after admission. As compared with nonusers, the risk was slightly higher among those who discontinued statin therapy upon admission. Similar results were obtained when patients were matched on propensity score.

Whether newly initiated or continued, early statin use was also associated with a reduced incidence of cardiac arrest, cardiogenic shock, cardiac rupture and ventricular tachycardia/ventricular fibrillation; however, incidence of recurrent AMI was not lowered.

"This analysis provides the strongest clinical evidence to date to support the hypothesis of early, direct cardioprotective effects of statins in AMI," the researchers noted. "However, adequately powered, prospective, randomized clinical trials are needed to confirm these findings before it can be concluded that there are direct cardioprotective effects of statins in AMI."

The study appeared in the September issue of the American Journal of Cardiology.

Generic Branding

Barr reports net earnings of $215 million in 2005; will settle patent dispute by acquiring rights to Mircette Barr Pharmaceuticals Inc. reported fourth-quarter net earnings of $42.1 million, or $0.40 per diluted share, on total revenue of $280.5 million compared with net earnings of $14.4 million, or $0.13 per diluted share, on revenue of $303.2 million during the fourth quarter of fiscal 2004.

The company reported net earnings of $215 million, or $2.03 per diluted share, on total revenue of $1.05 billion for the fiscal year ended June 30. This compares with the prior year's net earnings of $123.1 million, or $1.15 per diluted share, on total revenue of $1.31 billion.

Barr expects earnings per diluted share to be between $2.95 and $3.10 for the fiscal year ending June 30, 2006.

In separate news, Organon USA Inc., the human health care unit of Dutch chemical group Akzo Nobel NV, agreed to accept $142 million from Barr to purchase the New Drug Application for Organon's Mircette (desogestrel/ethinyl estradiol) and settle a patent dispute over the oral contraceptive.

The settlement would give Barr all rights to Mircette; Barr is also to pay $13.8 million to Mircette's patent holder, Saviant Pharmaceuticals Inc. Barr already markets a generic formulation of Mircette under the brand name Kariva.

As a result of the transaction, Barr recorded a pretax charge of $62.3 million, or approximately $0.37 per diluted share, in its financial statement for the quarter and year ended June 30, 2005.

Shares of Barr closed at $53.50, up $3.08, or 6.1 percent, in heavy trading on the New York Stock Exchange.

Generic Branding

Generic Branding
Wyeth Wyeth opened a new 1.2 million-square-foot biotech facility in South County Dublin, Ireland. The site is "one of the largest integrated biotech manufacturing facilities in the world," Wyeth said, adding that the new facility will complement the company's Andover, Mass., facility. At the new site, Wyeth plans to produce its intravenous antibiotic Tygacil (tigecycline), which was approved by the Food and Drug Administration in June to treat complicated intra-abdominal infections and complicated skin and skin structure infections, along with Wyeth and Amgen Inc.'s arthritis and psoriasis treatment, Enbrel (etanercept), and other biotech products.

Generic Branding

Generic Branding
King Pharmaceuticals Inc. King Pharmaceuticals Inc. and Inyx Inc. entered into a collaboration in connection with two of King's asthma treatments, Intal (cromolyn sodium) and Tilade (nedocromil sodium). The collaboration, which encompasses several 10-year agreements with renewal options, includes the ongoing development of an Intal formulation that uses an environmentally friendly propellant. Inyx said it expects to earn "significant" revenue and income as a result of its new business relationship with King, starting as early as next year. King and Inyx will comarket the drugs and share net revenue. King will continue to market the products to primary care physicians and hospitals, and Inyx will sell directly to specialists.

Generic Branding

Generic Branding
Caremark Rx Inc. Caremark Rx Inc.'s subsidiary, AdvancePCS, reached a settlement agreement with the U.S. government regarding allegations made against AdvancePCS before Caremark acquired the company in the spring of 2004. Caremark and other pharmacy benefit managers have been under federal or state investigation for various issues, including discounts and payments from pharmaceutical companies to promote certain drugs. The $137.5 million payment will settle the disputed claims, although Caremark said the government agreed that the settlement "is not intended to be, and shall not be understood as, an admission of liability or wrongdoing by AdvancePCS." Additionally, both AdvancePCS and Caremark agreed to abide by a corporate integrity agreement, with Caremark overseeing AdvancePCS' "compliance obligations."

Generic Branding

Generic Branding
Indevus Pharmaceuticals Inc. Indevus Pharmaceuticals Inc. initiated a Phase III clinical program for Sanctura XR (trospium chloride), a once-daily formulation of Sanctura, in patients with overactive bladder. The program consists of two 12-week, double-blind, placebo-controlled studies including a total of 1,200 adults; its goal is to evaluate the extended-release formula on urinary frequency, urge incontinence and other related symptoms, the company said. Indevus expects to file a New Drug Application with the Food and Drug Administration in the second half of 2006.

Generic Branding

Generic Branding